Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

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The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.

Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months

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Ages Eligible for Study:

6 Weeks to 8 Weeks (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.

Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Written informed consent obtained from the parents or guardians of the subject.

Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.

Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.

Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.